drugset / Trial / NCT05149924
Efficacy and Safety of QL1012 in Women for Assisted Reproductive Treatment
RandomizedParallel-groupSingle-blindTreatment
Summary
The study is conducted to confirm equivalence between QL1012 (a new biosimilar formulation of Recombinant Human Follicle-stimulating Hormone) and Gonal-f® with respect to the number of oocytes retrieved in women for assisted reproductive treatment.
Timeline
- Start
- 2018-10-31
- Primary completion
- 2019-10-17
- Completion
- 2019-10-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gonal-f | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Comparator | Gonal-f | Protein / enzyme biologic | 450 iu | Subcutaneous |
| Subject | QL1012 | Protein / enzyme biologic | 75 iu | Subcutaneous |
| Subject | QL1012 | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Subject | QL1012 | Protein / enzyme biologic | 450 iu | Subcutaneous |